Note: Although this FDA-483 is an
accurate representation of the original FDA-483 issued to the firm, it is not an exact
copy. Slight modifications to the original FDA-483 have been made to accommodate its
conversion to the HTML format. A scanned copy of the original FDA-483 is available in PDF format on this website. |
DEPARTMENT
OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION |
DISTRICT
OFFICE ADDRESS AND PHONE NUMBER
158-15 Liberty Ave.
Jamaica, NY 11433
(718) 340-7000 Fax:(718) 662-5661 |
DATE(S)
OF INSPECTION 04/12/2005 -
05/06/2005* |
FEI
NUMBER
1317056 |
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: John
F. Watkins, Plant Quality Manager |
FIRM
NAME
Boston Scientific Corp |
STREET
ADDRESS
10 Glens Falls Tech Park
|
CITY,
STATE AND ZIP CODE
Glens Falls, NY 12801-3864
|
TYPE
OF ESTABLISHMENT INSPECTED
Medical Device Manager |
This document lists
observations made by the FDA representative(s) during the inspection
of your facility. They are inspectional observations, and do not
represent a final Agency determination regarding your compliance.
If you have an objection regarding an observation, or have implemented,
or plan to implement, corrective action in response to an observation,
you may discuss the objection or action with the FDA representative(s)
during the inspection or submit this information to FDA at the address
above. If you have any questions, please contact FDA at the phone
number and address above. |
The observations
noted in this Form FDA-483 are not an exhaustive listing of objectionable
conditions. Under the law, your firm is responsible for conducting
internal self-audits to identify and correct any and all violations
of the quality system requirements. |
DURING AN INSPECTION OF YOUR FIRM I OBSERVED:
OBSERVATION 1
Procedures for acceptance or rejection of incoming product were
not established.
Specifically,
a) Quality Assurance Procedure #6V62 titled Incoming Inspection
of Low Profile Plastic Port Subassemblies was incorrect to established
product specification for dimensional height. Firm's product specifications
for the port dimensional height single valve were established [REDACTION].
Firm's Incoming Inspection of Low Profile Plastic Port Subassemblies
QA 6V62 and associated blueprint for the Port, LP, with Septum had
a product specification for the port dimensional height single valve
established at [REDACTION].
b) Quality Assurance Procedure #6V56 titled Incoming Inspection
of Introducer / Sheath did not adequately define inspection / testing
of the received Introducer / sheath for proper scoring to allow
for the designed peeling activity.
——
Annotation: Promised to correct. |
OBSERVATION 2
A process whose results
cannot be fully verified by subsequent inspection and test has not
been fully validated and approved according to established procedures.
Specifically,
a) Vaxcel PASV Low Profile Port with PASV valve devices are tested
in-process per Manufacturing Operation Code #3043 using the [REDACTION]
test to assure no bubble formation (leaks). Firm has not validated
the [REDACTION] test.
b) Vaxcel PASV Low Profile Port with PASV valve devices product
specification is 'no leaks at [REDACTION].
Firm uses a product specification of [REDACTION]
test'. Firm has not validated the [REDACTION] test'
against the established product specification [REDACTION]
product specification test methods are equivalent.
c) Vaxcel PASV Low Profile Port with PASV valve devices product
specification is '[REDACTION]test'. Firm releases
product port assembly with valve at [REDACTION]
is observed. Firm has not validated the [REDACTION]
bubbled is observed against the product specification of '[REDACTION]
test'.
——
Annotation: Promised to correct. |
OBSERVATION 3
Procedures for acceptance or rejection of finished device production
runs, lots, or batches were not established and implemented.
Specifically,
a) Vaxcel Low Profile, Mini, and Standard Chest Implant Ports with
PASV valve were released and distribution without a final acceptance
conducted post sterile or equivalent which assures that the device
meets all specifications.
b) VAXCEL PASV PICCs were released and distribution without a final
acceptance conducted post sterile or equivalent which assures that
the device meets all specifications.
——
Annotation: Under consideration. |
OBSERVATION 4
Acceptance procedures to ensure that specified requirements for
in-process product are met were not established.
Specifically,
a) Quality Assurance Procedure #6W39 Rev.1 dated 4/30/04 was not
adequately defined so that the quality assurance operator would
conduct acceptance activity to assure that the correct proximal
fitting red color is aligned with larger lumen.
——
Annotation: Corrected and verified.
|
OBSERVATION 5
The device history record does not include complete acceptance
records that demonstrate the device is manufactured in accordance
with the device master record.
Specifically,
a) Audit of 38 MFG 100% Leak Test Ports, Port Traceability form
Attachment A records which are covered by Manufacturing Operation
Codes #3043 found that the leak test device history record failed
to identify test method used, pressure, and time tested.
——
Annotation: Promised to correct.
|
OBSERVATION 6
Complaint handling procedures have not been implemented to ensure
that all complaints are evaluated to determine whether the complaint
should be filed as a Medical Device Report.
Specifically,
a) Introducers/Sheaths [REDACTION] used in the
Vaxcel Mini, Standard, & Low Profile Port with PASV valves had
7 (640938, 644265, 647007, 647080, 650077, 651813, 651815) of 21
complaints of malfunction involved with patient - procedure were
not filed as MDR.
b) Vaxcel Mini & Standard Chest Implant Ports had 3 (639511,
639513, 639514) of 9 complaints of malfunction involved with patient
- procedure was not filed as MDR.
|
OBSERVATION 7
A correction or removal, conducted to reduce a risk to health posed
by a device, was not reported in writing to FDA.
Specifically,
a) Vaxcel 4.5Fr Dual Lumen PASV PICC Catheters were being recalled
because the firm installed the smaller capacity proximal fitting
onto the larger handling volume lumen and the larger capacity proximal
fitting onto the smaller handling volume lumen during production
which was not picked up during inspection.
|
OBSERVATION 8
Complaints involving the possible failure of a device to meet any
of its specifications were not investigated where necessary.
Specifically,
a-1) Introducer/sheaths [REDACTION] used in the
Vaxcel Mini, Standard, and Low Profile Port with PASV valve kits
had 16 (636342, 641509, 642733, 644265, 645048, 647007, 647080,
652157, 652152, 652154, 650077, 651727, 651772, 651773, 651813,
651815) of 21 complaint / failure investigations which did not report
root cause and follow up.
a-2) Vaxcel Low Profile Port With PASV valve kits had 2 (646860
& 649881) of 5 complaint/failure investigations which did not
report root cause and follow up.
a-3) Vaxcel Mini & Standard Port with PASV valve kits had 6
(628403, 634224, 637445, 639511, 639513, 639514) of 9 complaint/failure
investigations which did not report root cause and follow up.
a-4) Vaxcel PASV PICCs (IR/5/2) had 14 (634999, 636072, 636073,
636074, 636075, 636077, 636083, 634185, 641152, 641153, 641155,
641575, 641578, 641579) of 19 complaint/failure investigations which
did not report root cause and follow up.
a-5) Vaxcel PASV PICCs (IR/5/1) had 4 (637687, 637500, 645956,
645957) of 5 complaint/failure investigations which did not report
root cause and follow up.
a-6) Vaxcel PASV PICCs (CK/5/2) had 10 (635156, 635300, 637348,
637349, 637350, 637352, 637354, 637355, 644796, 645595) of 14 complaint/failure
investigations which did not report root cause and follow up.
b-1) Introducer/sheaths [REDACTION] used in the
Vaxcel Mini, Standard, and Low Profile Port with PASV valve kits
had 12 (636342, 640042, 641509, 644265, 645048, 652157, 652152,
652154, 650077, 651727, 651813, 651815) of 21 complaints failed
to request and obtain complainant product, failure to follow-up
in a timely manner to get failed device, and/or GF RCM not following
up to assure failed device is obtained from complainant.
b-2) Vaxcel Mini & Standard Port with PASV valve kits had 3
(639511, 639513, 639514) of 9 complaints failed to request and obtain
complainant product, failure to follow-up in a timely manner to
get failed device, and/or GF RCM not following up to assure failed
device is obtained from complainant.
b-3) Vaxcel PASV PICCs (IR/5/2) had 4 (641576, 641575, 641578,
641579) of 9 complaints failed to request and obtain complainant
product, failure to follow-up in a timely manner to get failed device,
and/or GF RCM not following up to assure failed device is obtained
from complainant.
b-4) Vaxcel PASV PICCs (IR/5/1) had 2 (645556 & 6455957) of
5 complaints failed to request and obtain complainant product, failure
to follow-up in a timely manner to get failed device, and/or GF
RCM not following up to assure failed device is obtained from complainant.
|
OBSERVATION 9
Procedures have not been established to ensure that device history
records for each batch, lot, or unit are maintained to demonstrate
that the device is manufactured in accordance with the device master
record and the Quality Systems regulation.
Specifically,
a) Quality Assurance Procedure #6V87 requires that the original
signed Port Traceability form completed during the QA inspection
of assembled Vaxcel Chest Ports with Attached lock are removed from
the device history record and replaced with a photocopy of the completed
record in the device history record. Audit of 38 device history
records for the Vaxcel Chest Ports Port Traceability forms found
13 photocopies present in the respective production device history
record. Review found that the firm had 12 of the 13 original Port
Traceability forms in a different folder in Regulatory Affairs but
was unable to locate the 13th original lot #917111.
——
Annotation: Promised to correct. |
OBSERVATION 10
Records of complaint investigations do not include device identifications
and control numbers used.
Specifically,
a) Introducer /Sheath [REDACTION]and used in Vaxcel
Mini, Standard, & Low Profile PASV Port with valve kits received
as complaints had 6 (652157, 652152, 652154, 650077, 651813, 651815)
of 21 which failed to list lot number of product.
b) Vaxcel Low Profile Chest Implant Ports had 2 (646355 & 648652)
of 5 which failed to list lot number of product.
c) Vaxcel Mini & Standard Chest Implant Ports had 4 (634224,
639511, 639513, 639514) of 9 which failed to list lot number of
product.
d) Vaxcel PASV PICCs (IR/5/2) had 12 (636072, 636073, 636074, 636075,
636077, 636083, 636084, 634185, 637896, 637898, 641153, 641155)
of 19 which failed to list lot number of product.
e) Vaxcel PASV PICCs (IR/5/1) had 3 (637687, 637900, 639866) of
5 which failed to list lot number of product.
f) Vaxcel PASV PICCs (CK/5/2) had 9 (637349, 637350, 637352, 637354,
637355, 643025, 645595, 645593, 643023) of 14 which failed to list
lot number of product. |
* DATES OF INSPECTION
04/12/2005(Tue), 04/14/2005(Thu), 04/15/2005(Fri), 04/19/2005(Tue),
04/21/2005(Thu), 04/22/2005(Fri), 05/06/2005(Fri)
|
FDA EMPLOYEE'S NAME, TITLE, AND SIGNATURE:
[Handwritten Signature]
Michael G Sinkevich, Investigator |
SEE
REVERSE
OF THIS
PAGE |
|
|
DATE
ISSUED 05/06/2005 |
FORM FDA 483 (7/00) PREVIOUS EDITION OBSOLETE
INSPECTIONAL OBSERVATIONS
Reverse Text on Page: The observations of objectional conditions and practices listed
on the front of this form are reported:
- Pursuant to Section 704(b) of the Federal Food, Drug and
Cosmetic Act, or
- To assist firms inspected in complying with the Acts and
regulations enforced by the Food and Drug Administration.
|
Section 704(b) of the Federal Food, Drug, and Cosmetic
Act (21 USC374(b)) provides: “Upon
completion of any such inspection of a factory, warehouse, consulting laboratory, or other
establishment, and prior to leaving the premises, the officer or employee making the
inspection shall give to the owner, operator, or agent in charge a report in writing
setting forth any conditions or practices observed by him which, in his judgement,
indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole
or in part of any filthy, putrid, or decomposed substance or (2) has been prepared,
packed, or held under insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health. A copy of such report
shall be sent promptly to the Secretary.” |
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